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T03-75 |
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As a precaution, the Food and Drug Administration (FDA) is alerting U.S. residents to the recent recall of certain GlaxoSmithKline “Diskus” medicines sold in Canada to treat asthma and chronic obstructive pulmonary disease (COPD). The three asthma products – Ventolin Diskus, Flovent Diskus, and Serevent Diskus -- were recalled in Canada November 12th, 2003, because the products’ drug delivery system may not function properly and may deliver too little of the drug – or none at all. Canadian patients are being advised to return the affected product to the pharmacy or physician’s office where it was obtained in order to get a replacement.
FDA emphasizes that FDA-approved Diskus products (Advair and Serevent) sold in the U.S. through legitimate marketing channels are not subject to this recall. But because some U.S. residents have obtained precription drugs from Canada and elsewhere through on-line or storefront operations, they may have received these potentially substandard and ineffective products.
The specific affected lots of the products recalled in Canada, and additional information from the product manufacturer, are available on the Canadian website of GlaxoSmithKline at http://www.gsk.ca/en/media_room/news/public_advisory_en.pdf
U.S. patients who may have obtained these affected medications from Canada who have questions or concerns about these products should discuss them with their physician, pharmacist, or health care provider. Consumers and Healthcare professionals have been asked to report any suspected adverse events associated with the use of these products directly to GSK or Health Canada using the following contact information:
GlaxoSmithKline Inc.
7333 Mississauga road N
Mississauga, Ontario
L5N
6L4
Telephone: 1-800-387-7374
Canadian Adverse Reacton Monitoring Program (CADRMP)
Marketed Health Products
Directorate
HEALTH CANADA
Address Locator: 0201c2
Ottawa, Ontario K1A
1B9
Toll free phone: 1-866-234-2345
Toll free fax: 1-866-678-6789
cadrmp@hs-sc.gc.ca
FDA reminds patients that asthma, COPD and related diseases can be serious and life-threatening. No one taking medications for these conditions should stop taking them abruptly without first talking to their physicians. FDA also emphasizes that all asthma drugs should be given as part of a comprehensive treatment plan that takes into account the patient’s disease severity and fully educates patients about the disease and its proper treatment.
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